GE Healthcare Recalls Giraffe OmniBed Infant Warmers Due to Latch Defect
GE Healthcare is recalling Giraffe OmniBed infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric. The hazard involves a structural defect leading to a potential patient fall, which aligns with the criteria for severe injury risk.
Plain-English summary
GE Healthcare, LLC is recalling 23,693 units of the Giraffe OmniBed infant warmer. The recall is due to a defect where bedside panels and portholes can appear closed without being latched. This issue creates a potential risk of patient falls.
The affected units were distributed worldwide. The recall covers specific model numbers, including 6650-0XXX-XXX, 2074920-00X-XXXXXX, and various M-series models. An update dated June 3, 2021, indicates that all model numbers and units are affected.
Healthcare facilities should stop using the affected devices and contact GE Healthcare for instructions on repair or replacement. The U.S. Food and Drug Administration has classified this as a Class I recall.
The recalled product
- Product
- Giraffe OmniBed infant warmer
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Infant Warmer
- Affected units
- 23,693
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- HighSIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
FDA (Devices) · 2022-07-27
Same hazard · patient fall
See all →- SevereHillrom LikoScale patient lift components may falsely latch and detach
FDA (Devices) · 2025-07-16
- SevereHillrom Q-Link 13 patient lift components may falsely latch and detach
FDA (Devices) · 2025-07-16
- CriticalAllura Xper FD20 Fluoroscopy Table Mattress Issue Causes Fall Risk
FDA (Devices) · 2025-02-26
- SevereMedical imaging device patient table mattress may cause patient falls
FDA (Devices) · 2025-02-26
- SeverePhilips Allura Xper FD20/20 Imaging Table Mattress Recall
FDA (Devices) · 2025-02-26